FDAFDA · Food and drugs·Recall number D-1439-2019
Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01
Published July 10, 2019 · Recall initiated: September 25, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amneal Pharmaceuticals, Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot #: HL06015, HL06115, Exp. 10/2017
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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